Prasugrel Impurity 12 CAS 1100905-45-0
| CAS No. | 1100905-45-0 |
| Molecular Formula | C11H11FO2 |
| Molecular Weight | 194.20 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Prasugrel Impurity 12.
Prasugrel Impurity 12 (CAS 1100905-45-0) is a certified pharmaceutical impurity reference standard with the molecular formula C11H11FO2 and a molecular weight of 194.20 g/mol.
Based on its molecular formula C11H11FO2, Prasugrel Impurity 12 contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 194.20 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
As a certified reference material (CRM), Prasugrel Impurity 12 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C11H11FO2 |
| Molecular Weight | 194.20 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >90% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | F-containing |
Related Prasugrel Standards
- Prasugrel Hydrochloride EP Impurity G (CAS 1391054-37-7)
- Prasugrel Impurity 27 HCl (CAS 115473-15-9)
- Prasugrel Impurity 12 (CAS 1151904-85-6)
- Prasugrel Impurity 36 (CAS CATO-C4X-108636)
- Prasugrel Impurity 15 (CAS 150322-73-9)
- Prasugrel Impurity 8 (CAS 1071842-61-9)
- Prasugrel Impurity 9 (CAS 952722-64-4)
- Prasugrel Impurity 27 (CAS 88106-31-4)
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